In 2010, there were 15.4 million Medicare beneficiaries over the age of 65 with four or more chronic conditions, of which 43% were hospitalized at least once during the year. Further, an estimated 39% of the elderly population has some type of disability (i.e., difficulty in hearing, vision, cognition, ambulation, self-care, or independent living). For a considerable number of individuals, these types of disabilities may make it difficult to adhere to a medication schedule.
Many of these individuals may depend on untrained volunteers, family, or friends to help them manage their medications. Current estimates state there are 34.2 million Americans that have provided unpaid care to an adult 50 years old or over. Approximately a quarter of these caregivers provide 41 or more hours of care per week, typically for a close relative who has been hospitalized in the past year. These caregivers often experience stress, physical and financial strain, and adverse impacts on their health while they perform complex medical and nursing responsibilities.
Furthermore, the U.S. Census Bureau anticipates population growth of 60% for the age group over 65 years old and a population decline of 1% in the age group 45 to 64 years old between 2014 and 2030. This major demographic shift may significantly affect the support system for the elderly. Even individuals that receive assistance from a paid home health aide may still have issues managing their medications, as the majority of home health aides do not administer medication or provide assistance with self-administration of medications. Many of these home health aides are prohibited to administer medication by state law, or have not obtained the required medication technician certification required by most nurse delegation programs due to cost and potential liability concerns.
Even though the elderly currently comprise only 12% of the population, they consume 33% of all prescription drugs with two out of five Medicare beneficiaries taking five or more prescription medications. The large number of medications prescribed to the elderly and chronically ill, combined with the cognitive and sometimes physical challenges of following multiple medication regimens, reduce a patient's ability to fully benefit from prescribed medications. It has been estimated that 20-30% of medication prescriptions are never filled and 50% of the time medication is not continued and completed as prescribed. Polypharmacy, defined as taking multiple medications concurrently to treat coexisting diseases, with the elderly typically leads to medication non-adherence and is estimated to occur among 25%-75% of elderly patients, with the rate of occurrence increasing in proportion to the number of drugs and daily dosages prescribed. Lack of medication adherence can result in disease progression, death and higher costs to the healthcare system. Furthermore, non-adherence was estimated to account for 10% of hospital admissions and 23% of nursing home admissions. The New England Healthcare Institute calculates non-adherence along with suboptimal prescribing, drug administration and diagnosis could result in up to $290 billion in losses annually in the US. Additionally, estimates report the effect of poor medication adherence results in approximately 125,000 deaths in the US annually.
There are a growing number of studies that have documented net savings associated with higher medication adherence across a range of common chronic conditions. One study demonstrated improved medication adherence might provide a net economic return for certain chronic conditions, including diabetes, hypertension, hypercholesterolemia and congestive heart failure. Consequently, the study noted increased adherence to drug therapy reduced a patient's need for medical services, including hospitalizations and emergency room visits.
However, independent management of drug administration is a relatively ineffective way to increase medication adherence. Seven-day pillboxes are probably the most common products used, but they require manual sorting of pills on a weekly basis. This is an unreliable and cumbersome process that sometimes requires assistance from a caregiver or pharmacist. One study noted that the majority of elderly patients may be unable to open and access their medications from multi-compartment pillboxes with ease, and cognitively impaired patients may experience even more difficulties than others. Forgetfulness is a major factor contributing to non-adherence, with an estimated 30% of patients with chronic conditions asserting forgetfulness. This poses a further challenge to independent seniors, which are at a higher risk of forgetting to take their medication if they experience increased busyness. However, most pillboxes do not provide interactive reminders or instructions, and are thus inadequate solutions in this respect. Another downside to pillboxes is that they may promote cross-contamination, as different pills are placed inside a small compartment together.
Smart phone applications have been developed to assist in medication adherence through reminders and alerts, but are not comprehensive solutions addressing the specific needs for patients with several chronic conditions and potentially suffering from physical and cognitive impairments. As a result, reminders and alarms alone are not likely to improve adherence unless they are designed to provide relevant information with interactive features to facilitate addressing these concerns on a timely basis. Lastly, there are mail order pharmacies that specialize in pre-sorting prescription pills into pill pouches or blister packs and shipping directly to patients. However, the process of managing medication changes is cumbersome and apt to wasting a supply of medication. Although the pre-sorted packets help to simplify the medication administration, this is clearly not an interactive system with real-time capability to remind, instruct, monitor, and alert the status of the patient's medication adherence record.
Currently, there are no medication adherence solutions on the market that are comprehensive, fully automated, and requires no programming by the user. In addition, critical information such as medication formularies, e-prescriptions and pharmaceutical databases are kept in “silos” and are not readily available in an integrated fashion, making it difficult to retrieve data for contextual analysis. Consequently, even the more advanced medication administration products on the market still require manual pill sorting and programming of alarms and reminders—a challenging task for this at-risk population.
Accordingly, there exists a need for a device that provides an effective solution for both patients and health care providers regarding the patient's adherence or compliance with complicated medication regimens. In particular, there exists a need for an automated medication adherence system to help organize the dispensing of many different sizes and shapes of pills and capable of managing a schedule of different pills to be taken at different scheduled times. Such a system should enhance the interaction between the patient and health care provider by allowing the health care provider to be alerted when the patient is not taking the medication according to the medication schedule.